New Pennsylvania law mandates patients be notified of 'abnormal' scans

por John R. Fischer, Senior Reporter | November 06, 2019
Patients living in Pennsylvania may now be more aware of whether they require a follow-up medical imaging scan, thanks to a new state law.

Known as the Patient Test Result Information Act or Act 112, the legislation mandates that imagers notify patients directly of any abnormal findings found in initial scans. It is an added requirement to the one that requires they send the report to the healthcare practitioner (HCP) that ordered the exam, according to ImproveDx, the newsletter of the Society to Improve Diagnosis in Medicine.

“Improving communication of test results is one of our biggest areas of opportunity when it comes to diagnostic excellence,” Rebecca Jones, the director of the Pennsylvania Patient Safety Authority’s innovation and strategic partnerships and its Center of Excellence for Improving Diagnosis, told ImproveDx. She adds that the center is helping state providers “develop a qualitative understanding of the current level of performance regarding diagnostic safety,” in anticipation of the full enactment of Act 112.

Introduced by former state representative Marguerite Quinn (R.), the law was signed in October 2018 by Governor Tom Wolf and set to go completely into effect on December 23 of that year. A grace period, however, was enacted to give hospitals a year to develop policies that ensure they comply with the law. Those found to not be in compliance over the past year have received letters of helpful information on how they must be. Those found to be outside compliance, including for patient notifications, after the end of the grace period in December 2019 will face sanctions.

Among the requirements are mandates to provide patients the name of the HCP that ordered the test, the date of the test, the date in which the findings were relayed to the HCP, and instructions for how patients can obtain a copy of the full radiology report. Information must be relayed to patients in person at the time of the exam, or by mail, email, fax, or through a patient portal within 20 days of when the report was provided to the HCP.

Emergency departments that provide imaging services to patients and inpatients are exempt, as are services pertaining to routine obstetrical ultrasound exams for monitoring fetal development, and diagnostic radiographs (as in all X-ray exams). The exemption prevents patients who undergo X-rays from being notified directly of any incidental findings, according to ImproveDx, which reports that the status of nuclear medicine exams, endoscopy, echocardiograms and imaging for patients under observation in hospitals has also not been made clear. In addition, there are no guarantees that patients will comprehend the meaning of the notification or will contact their HCPs for follow-up.

Other concerns are the variation among providers of what characterizes a significant abnormality or anomaly, and worries that the law will cause imaging providers to expand their definition of "abnormal findings" to be safe, thereby potentially exposing more patients to unnecessary exams and greater fear and anxiety.

“The statute attempts to define ‘significant abnormality’ as ‘a finding by a diagnostic imaging service of an abnormality or anomaly which could cause a reasonably prudent person to seek additional or follow-up medical care within three months’,” said law firm Post & Schell. “This is decidedly vague, which leaves some room for judgment and interpretation by both the entity and the practitioner.”

Specific details of what the sanction will entail have not yet been determined.

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